Observational studyAnnals of surgical oncology2026
A Prospective Multicenter Comparative Cohort Study of Neoadjuvant Sintilimab Plus Chemotherapy and Chemoradiotherapy in Resectable Clinical Node-Positive Esophageal Squamous Cell Carcinoma.
Observational study in Annals of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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22 authors.
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Abstract
backgroundNeoadjuvant chemoradiotherapy (CRT) remains the standard treatment for locally advanced esophageal squamous cell carcinoma (ESCC), although distant recurrence continues to limit long-term survival. Neoadjuvant chemoimmunotherapy (CIT) has emerged as a potential systemic-focused alternative. This prospective multicenter study explored the comparative outcomes of neoadjuvant sintilimab plus chemotherapy versus CRT in resectable, clinical node-positive ESCC.
methodsConsecutive adults with resectable, clinical node-positive (cN+) ESCC were enrolled across four academic centers. The patients received neoadjuvant sintilimab plus platinum-based chemotherapy (CIT) or standard CRT according to predefined institutional pathways in a nonrandomized design (2:1 enrollment). The primary endpoint was pathologic complete response (pCR). The secondary endpoints included nodal downstaging, perioperative outcomes, disease-free survival (DFS), overall survival (OS), and exploratory analyses of pretreatment inflammatory biomarkers.
resultsThe 63 patients in this study completed neoadjuvant therapy followed by esophagectomy (CIT [n = 42] or CRT [n = 21]). The pCR rate was numerically higher with CRT than with CIT (52.4 % vs 31.0 %; p = 0.110). Nodal clearance was comparable (ypN0: 85.7 % vs 78.6 %; p = 0.735) with high R0 resection rates in both groups. During a median follow-up period of approximately 22 months, DFS did not differ significantly, whereas OS showed separation on unadjusted Kaplan-Meier analysis (p = 0.04, log-rank). Exploratory analyses showed no significant associations between pretreatment inflammatory biomarkers (neutrophil-to-lymphocyte ratio [NLR], monocyte-to-lymphocyte ratio [MLR], platelet-to-lymphocyte ratio [PLR], systemic immune-inflammation index [SII]) and pathologic response. Higher baseline SII was associated with OS in unadjusted comparisons.
conclusionsIn this prospective nonrandomized cohort of clinical node-positive ESCC, CIT achieved nodal downstaging and R0 resection comparable with CRT but lower pCR. The observed survival difference should be interpreted cautiously and warrants validation in randomized trials.
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